EA-4/18 - guidance on the level and frequency of proficiency testing participation

EA-4/18 INF: 2010

Guidance on the level

and frequency of proficiency

expression
testing participation

PURPOSE
The aim of this paper is to promote harmonization between Accreditation Bodies on how the
level and frequency of participation in PT is evaluated and to assist laboratories in determining
their own levels and frequency of participation.

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Authorship
The publication has been written by the EEE-PT Working Group Proficiency Testing in
Accreditation.

Official language
The text may be translated into other languages as required. The English language version
remains the definitive version.

Copyright
The copyright of this text is held by EA. The text may not be copied for resale.

Further information
For further information about this publication, contact your national member of EA.
Please check our website for up-to-date information http://www.european-accreditation.org

Category: Application documents and Technical /Advisory documents for Conformity

Assessments Bodies

EA-4/18 is a Guidance/Informative document

Date of Approval: March 2010

Date of Implementation: immediate

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CONTENTS

1. Introduction 4

2. Terms and Definitions 5

3. General Aspects 5

4. Level and Frequency of Participation 6

5. Case Studies 7

Case Study 1 Environmental Chemistry Testing Laboratory 8

Case Study 2 Microbiology Testing Laboratory 9

Case Study 3 Clinical Testing Laboratory 10

Case Study 4 Physical Testing Laboratory 11

Case Study 5 Matrix Approach (Clinical Chemistry) 13

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1. Introduction
The standard ISO/IEC 17025:2005 General Requirements for the competence of testing
and calibration laboratories (sub-clause 5.9) establishes that the laboratory shall have
quality control procedures for monitoring the validity of tests results and that this monitoring
shall be planned. Among others, the standard refers to participation in Proficiency Testing
(PT) as one of the tools laboratories may use to achieve this objective.1

ISO/IEC 17011:2004 Conformity assessment General requirements for accreditation

bodies accrediting conformity assessment bodies, the standard to which ILAC MLA
Signatories are required to operate, requires that The accreditation body shall ensure that
its accredited laboratories participate in proficiency testing or other comparison
programmes, where available and appropriate, and that corrective actions are carried out
when necessary. The minimum amount of proficiency testing and the frequency of
participation shall be specified in cooperation with interested parties and shall be
appropriate in relation to other surveillance activities.2

In addition EA 3and ILAC4 have established specific policies regarding participation of

laboratories in PT activities. This paper, which has been prepared by the joint stakeholder
working group, EEE-PT, on Proficiency Testing is the result of extensive discussions and
helps the accreditation bodies in their implementation of these policies. The paper also
aims to promote harmonization between accreditation bodies on how the level and
frequency of participation in PT is evaluated and to assist laboratories in determining their
own levels and frequency of participation.

Note: This document is also applicable to medical laboratories and when used in such
instances reference to ISO/IEC 17025 should be read as ISO 15189.5

1 ISO/IEC 17025:2005 General Requirements for the competence of testing and calibration laboratories
2 ISO/IEC 17011:2004 Conformity assessment General requirements for accreditation bodies accrediting
conformity assessment bodies
3 EA-2/10 (Current Version) - EA policy for participation in national and international proficiency testing activities
4 ILAC-P9 (Current Version) - ILAC Policy for Participation in National and International Proficiency Testing Activities
5 ISO/IEC 15189:2007 Medical laboratories. Particular requirements for quality and competence

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2. Terms and Definitions

Proficiency Testing (PT): evaluation of participant performance against pre-established

criteria by means of interlaboratory comparisons6

Interlaboratory Comparison: organization, performance and evaluation of measurements

or tests on the same or similar items by two or more laboratories in accordance with
predetermined conditions6

Measurement Technique: The process of testing/calibrating/identifying the property,

including any pre-treatment required to present the sample, as received by the laboratory,
to the measuring device. (e.g. ICP-MS, Rockwell Hardness, PCR, Microscopy, Force
Measurement)

Property: The quantity being measured (e.g. Arsenic, Fat, Creatinine, Length, Hardness,
Force)

Product: The item that the measurement technique is being applied. (e.g. Soil,
Vegetables, Serum, Polystyrene, Concrete)

Level of Participation: The number of sub-disciplines that an organisation identifies within

its scope, and therefore the number of specific proficiency tests that should be considered
for participation

Frequency of Participation: This is how often a laboratory determines that it needs to

participate in PT for a given sub-discipline, this may vary from sub-discipline to sub-
discipline within a laboratory and between laboratories with the same sub-disciplines

Sub-discipline: An area of technical competence defined by a minimum of one

Measurement Technique, Property and Product, which are related. (e.g. Determination of
Arsenic in soil by ICP-MS)

3. General Aspects

The following aspects should be taken into consideration by accreditation bodies when
determining the suitability of a laboratorys frequency and level of participation in
proficiency testing:

(1) The laboratory should define its level and frequency of participation after careful
analysis of its other QA measures (especially those that are able to disclose, quantify
and follow the development of bias of a stated magnitude). The participation should be
made dependent on the extent to which other measures have been taken. Other types
of QA include, but are not limited to:
Regular use of (certified) reference materials
Comparison of analysis by independent techniques
Participation in method development/validation and/or reference material
characterisation studies
Use of internal quality control measures
Other Inter/Intra Laboratory Comparisons e.g. Analysis on blind samples within
the laboratory

6 ISO/IEC 17043:2010 Conformity assessment General requirements for proficiency testing

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(2) The level of risk presented by the laboratory, the sector in which they operate or the
methodology they are using. This can be determined, for example, by considering:
Number of tests/calibrations/measurements undertaken
Turnover of technical staff
Experience and knowledge of technical staff
Source of Traceability (e.g. availability of reference materials, national standards,
etc.)
Known stability/instability of the measurement technique
Significance and final use of testing/calibration data (e.g. forensic science
represents an area requiring a high level of assurance)

(3) Different types of PT that can be used by laboratories and should be accepted by
accreditation bodies, include:
PT organised by other independent organisations such as accreditation bodies or
organisations such as ILAC, EA, APLAC and IRMM
ILC organised by a sufficient number of laboratories as a one off or continual
exercise
Submission of an internal sample or object to another or more external laboratories
for the purposes of data comparison

(4) It must be recognised that there are sectors where participation in PT may be difficult,
due to the technical characteristics of the measurement, the lack of PT schemes, the
low number of existing laboratories in the sector, etc. For some fields PT may only be
possible or economically feasible for parts of the test/calibration undertaken (i.e. EMC
tests on simple objects for a limited number of quantities to be measured). In these
areas the suitability of other QA/QC measures is paramount.

(5) Any legislative requirements for frequency of type of PT participation.

4. Level and Frequency of Participation

The first step for the laboratories should be to identify the sub-disciplines that apply to them
for the tests/calibrations for which they are accredited.

Ideally a laboratory would participate in a specific PT for every measurement technique it

uses and for every property measured in every product. However it is acknowledged that
this is unlikely to be feasible, both logistically and economically. Therefore accreditation
bodies should expect laboratories to identify groups of sets of measurement techniques,
properties and products on which the outcome of a PT for one of these sets can be directly
correlated to the others sets of measurement techniques, properties and products
contained within the group. These groups of sets of measurement techniques, properties
and products are termed a sub-discipline.

A sub-discipline, as defined above, may contain more than one measurement technique,
property or product as long as equivalence and comparability can be demonstrated. The
first consideration for a laboratory, when determining a sub-discipline, is that it should
generally not contain different technical competences. Different technical competences can
usually be identified by the need for different qualifications, training, and use of different
equipment, knowledge or experience.

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When determining a sub-discipline it may be helpful to consider a stepwise approach

working up from measurement technique through properties to products. This is because it
is more likely that there will be several products and/or properties associated with one
measurement technique within a given sub-discipline than vice versa:

(i) With reference to the measurement technique: It is possible but not common to
include different measurement techniques in the same sub-discipline.

(ii) With reference to the property to be measured, determined or identified: It may be

possible to include more than one property (parameter) in the same sub-discipline.

(iii) With reference to products to be tested: It may be possible to include different

products in the same sub-discipline provided that the matrices, objects or materials
included, are of equivalent nature.

When a laboratory determines that more than one measurement technique, property or
product is classified under the same sub-discipline, accreditation bodies should evaluate
whether a laboratory can justify and demonstrate equivalence. This can usually be done by
e.g.:
The method validation data, or,
Use of the same standard method
Once the laboratory has defined its sub-disciplines the level of participation can be
deemed to have been defined. Accreditation bodies will also need to evaluate the
suitability of a laboratories frequency of participation, based on level of risk and should
expect a minimum frequency of participation for each sub-discipline to be set by the
laboratory.

It should also be considered that according to ISO/IEC 17025:2005 (5.9.1) the laboratory
should have quality control procedures (of which PT is one) and that these should be
planned. Therefore, once the level and frequency of participation is established,
laboratories should be expected to develop a proficiency testing strategy which takes into
account those factors highlighted in General Aspects points 1-5. The extent and content
of this strategy will depend upon the circumstances and scope of the individual laboratory.
This should form part of the laboratorys overall quality control strategy.
It is recommended that the strategy covers, at least, one accreditation cycle (period
between full reassessments), and that this strategy is reviewed by the laboratory for its
suitability on an annual basis, usually during the formal management review.
The classification of sub-disciplines may be different for every laboratory. For this reason,
accreditation bodies should expect laboratories to be able to justify the technical
arguments that have led to the laboratories decision on the level and frequency of
participation in PT. It is recommended that laboratories document this justification.

5. Case Studies

It is for each individual laboratory to consider how many sub-disciplines will adequately
cover the scope of their work and thus define their level and frequency of participation in
PT, which should be detailed in their PT strategy. A number of case studies have been
provided to illustrate how a laboratory might review their scope of work and thus derive the
number of sub-disciplines. However, these case studies are only examples of how this
could be approached and should not be regarded as strict and definitive; it is for the
accreditation body to discuss with each individual laboratory their PT strategy, on a case
by case basis.

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Case Study 1 Environmental Chemistry Testing Laboratory

Accredited testing activities performed by the laboratory:

Polychlorinated Biphenyls (PCB) by GC-MS in Soils and Sewage Sludge

Polyaromatic Hydrocarbons (PAH) by GC-MS in Soils and Sewage Sludge
Volatile Organic Compounds (VOC) by Purge and Trap GC-MS in Waters
Metals by ICP-MS in Soils, Sewage Sludge and Waters
pH in Soils, Sewage Sludge and Waters

Considerations for determinations of sub-disciplines:

For pH the laboratory identifies that it utilises the same standard ISO Method for all three
matrices (Soils, Waters and Sewage Sludges). This ISO Method has been validated against all
three matrices and therefore the laboratory identifies this as one sub-discipline

For the analysis of metals the laboratory identifies that it uses the same measurement
technique (ICP-MS) for all three matrices (Soils, Waters and Sewage Sludge). However, the
preparation of Water samples compared to Soils and Sewage Sludges is significantly different.
As such the laboratory identifies that it cannot declare this as one sub-discipline, but as the
methodologies for soils and sewage sludge are demonstrably comparable they can be.
Therefore the laboratory identifies two more sub-disciplines

For PAH and PCB analysis the laboratory identifies that it uses the same measurement
technique (GC-MS) and the extraction of the matrices (Soils and Sewage Sludge) is identical
for both matrices. However, via its initial validation of the methods it is apparent that PCB and
PAH are effected in different ways by variations in the methodology and therefore acceptable
performance or problematic performance on PCB would not necessarily mean the same for
PAH (and vice versa). Therefore the laboratory identifies two more sub-disciplines

For its VOC method the laboratory only has one matrix (water) to consider. However the
laboratory is aware that the method analyses several different properties that could potentially
react in different ways to problems with the method. Through its method validation data the
laboratory has demonstrated that the differing properties react in comparable ways to variations
in the method. Therefore the laboratory identifies one more sub-discipline.

Resulting sub-disciplines from this exercise:

Polychlorinated Biphenyls (PCB) by GC-MS in Soils and Sewage Sludge

Polyaromatic Hydrocarbons (PAH) by GC-MS in Soils and Sewage Sludge
Volatile Organic Compounds (VOC) by Purge and Trap GC-MS in Waters
Metals by ICP-MS in Soils and Sewage Sludge
Metals by ICP-MS in Waters
pH in Soils, Sewage Sludge and Waters

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Case Study 2 Microbiology Testing Laboratory

Accredited testing activities performed by the laboratory:

Enumeration of Escherichia coli in meat

Enumeration of Salmonella in meat
Enumeration of Escherichia coli in vegetables
Enumeration of Salmonella in vegetables
Enumeration of Escherichia coli in dairy products
Enumeration of Escherichia coli in drinking water
Enumeration of Escherichia coli in swimming pool water

Considerations for determinations of sub-disciplines:

For the enumeration of Escherichia coli, the laboratory identifies that it uses the same method
for the analysis of meat samples and for vegetable samples. This method has been validated
for these two sample matrix types and therefore the laboratory identifies this as one sub-
discipline. However, this method has not been validated for dairy products and the laboratory
uses a different method for such sample types. Thus this is identified as an additional sub-
discipline.

The laboratory uses a different method for the enumeration of Salmonella, from that which it
uses for the enumeration of Escherichia coli. However, it has been validated for both meat and
vegetable matrices, and thus the laboratory identifies this as one additional sub-discipline.

For the enumeration of Escherichia coli in water, although different sampling and pre-treatment
techniques are used for the collection of the samples, the method used (which is different to
that used for the food products) has been validated for both drinking water and swimming pool
water, so this has been identified as one additional sub-discipline.

Resulting sub-disciplines from this exercise:

Enumeration of Escherichia coli in meat and vegetables

Enumeration of Escherichia coli in dairy products
Enumeration of Salmonella in meat and vegetables
Enumeration of Escherichia coli in drinking water and swimming pool water

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Case Study 3 Clinical Testing Laboratory

Accredited testing activities performed by the laboratory:

Screening for drugs of abuse in blood by ELISA and Liquid EIA

Screening for drugs of abuse in urine by ELISA and Liquid EIA
Confirmation of Amphetamine in blood and urine by GC-MS
Confirmation of Amphetamine in urine by GC-MS
Confirmation of Codeine in blood by GC-MS
Confirmation of Codeine in urine by GC-MS
Confirmation of Diazepam in blood by LC-MS-MS
Confirmation of Diazepam in urine by LC-MS-MS
Confirmation of Cocaine in blood by LC-MS-MS
Confirmation of Cocaine in urine by LC-MS-MS
Confirmation of EDDP in blood by LC-MS-MS
Confirmation of EDDP in urine by LC-MS-MS
Confirmation of Buprenorphine in blood by GC-MS-MS
Confirmation of Buprenorphine in urine by GC-MS-MS
Confirmation of Tetrahydrocannabinol in blood by GC-MS-MS
Confirmation of Tetrahydrocannabinol in urine by GC-MS-MS

Considerations for determinations of sub-disciplines:

The two methods used for the screening for drugs of abuse are different, however both have
been validated for use with both blood and urine samples. Thus the laboratory identifies these
as two sub-disciplines.

The three techniques used for the confirmation of various drugs of abuse are very different,
although each has been validated for both blood and urine matrices. Furthermore each different
detection system is considered to belonging to a separate sub-discipline. The drugs, although
coming from different families of products, are considered as equivalent from a competence
point of view. Thus the laboratory identifies that their confirmation tests consist of three
additional sub-disciplines.

Resulting sub-disciplines from this exercise:

Screening for drugs of abuse in blood and urine by ELISA

Screening for drugs of abuse in blood and urine by Liquid EIA
Confirmation of Amphetamine and Codeine in blood and urine by GC-MS*
Confirmation of Diazepam, Cocaine and EDDP in blood and urine by LC-MS-MS*
Confirmation of Buprenorphine and Tetrahydrocannabinol in blood and urine by
GC-MS-MS*

*Note: although the different drugs have been combined into one sub-discipline for each
detection system in terms of being equivalent from a competency point of view, this does not
suggest that they are equivalent in terms of method and laboratory performance. Therefore, the
laboratory would be expected to undertake such PTs specifically covering all the drugs in their
scope on a periodic basis. This would be expected to be clearly detailed in their proficiency
testing strategy.

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Case Study 4 Physical Testing Laboratory

Accredited testing activities performed by the laboratory:

Fracture toughness and fatigue crack growth of metals and metal alloys (ASTM E 399)
Tensile and compression testing of metals and metal alloys (example: EN 10002 part 1)
Tensile and compression testing of plastics (ISO 527-1)
Hardness test according to Brinell (ISO 6506), Vickers (ISO 6507), and Rockwell (ISO
6508)
Charpy impact test according to ISO 148-1
Determination of grain size (ISO 643)
Optical emission spectrometry (Quantification of chemical elements in steel matrix, in house
procedure)

Considerations for determinations of sub-disciplines:

Many accredited laboratories perform these named activities in the field of mechanical testing.
ISO, EN or ASTM standards describe the test methods. The standards usually define the
required equipment and other test related parameters. The named test activities are performed
using the same or different types of equipment requiring a specific calibration status and
specific knowledge of the staff performing these tests.

Fatigue crack growth and fracture toughness uses the same measurement technique and the
method (ASTM E 399)has been validated for metals and metal alloys. Therefore, the laboratory
identifies this as one sub-discipline.

Tensile testing and compression testing for metals and metal alloys are based on the same
measurement technique. However, the testing of fatigue crack growth encompasses the
measurement capability of tensile/compression testing and so the laboratory has identified no
need to undertake additional PTs for metals and alloys. (Note: participation in a PT for tensile
and compression testing would not be sufficient to cover the testing of fatigue crack growth).
Usually specific testing machines with different load capacities are used for flat or round
specimen. Basic requirements are on the load measurement, class 1 (1%), and measurement
of elongation (1%). The calculation of the results of these test methods are actually done by
computer systems, which are set up by the manufacturer of the machine or by the user who
has access to the software. Basically, the strength and the elongation of steel are determined in
this test. For specific materials, the machining of the specimen is critical for the behaviour of the
material and the related results.

For tensile test on plastics a similar test system can be used, but usually a lower load capacity
is necessary. The supplementary equipment is different because of the high ductility of plastics.
Additionally, the definitions of the parameters which are determined are different in ISO 527.
The equipment must be calibrated once a year, the use of reference material is limited to a
small number of laboratories. Therefore, the laboratory identifies this as an additional sub-
discipline since this uses a different method.

In the hardness tests according to Brinell (ISO 6506), Vickers (ISO 6507), a ball or a pyramid is
used to make an indentation in a surface of a steel material. After this step, the diagonals of the
indentation are measured and the hardness is of the material is calculated. In the related ISO
6506-1 and 6507-1 series, the requirements on the direct calibration status of the equipment
(load, indenter, length measurement device) are defined. They must be repeated once a year,
and the use of certified reference material prior to a test is mandatory. Thus the laboratory
identifies an additional sub-discipline for these two methods.

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The Rockwell (ISO 6508-1) hardness test uses a different measurement procedure compared
to Brinell and Vickers. According to ISO 6508 different types of indenters can be used to make
an indentation on a metals surface under pre- defined loading conditions. In this test the depth
of the indentation is measured using the specific test procedure. The ISO standard requires
calibration and the use of certified reference material. Therefore this is identified as an
additional sub-discipline by the laboratory

The Charpy impact test standard, ISO 148-1, defines the specimen dimensions. The test
equipment is calibrated once a year, and the Standard requires additionally specific reference
material for indirect calibration of the whole test setup. The impact energy is measured. Thus
another sub-discipline is identified by the laboratory

For the determination of grain size (ISO 643), the surface of a steel is prepared in a specific
way, grinding, polishing, etching to mark the grain boundaries of the material. After this
preparation step, a microscope with calibrated magnification is used to measure the size of the
grains and calculate the relevant parameters according to the standard. The laboratory
identified this as another sub-discipline.

Optical emission spectrometry is used by many laboratories to identify steel alloys. Certified
reference materials and secondary in-house standards are used to calibrate the equipment.
This is identified by the laboratory as an additional sub-discipline.

Resulting sub-disciplines from this exercise:

Fracture toughness and fatigue crack growth of metals and metal alloys
Tensile test on plastics
Hardness test by Brinell or Vickers
Hardness test by Rockwell
Charpy impact test
Determination of grain size
Optical emission spectrometry

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Case Study 5 Matrix Approach (Clinical Chemistry)

Accredited testing activities performed by the laboratory:

FSH by Chemiluminescence in blood
LH by Chemiluminescence in blood
Folic acid by Chemiluminescence in blood
Calcium by Electrochemistry in blood and urine
Potassium by Electrochemistry in blood and urine
Cryoglobulins by Electrophoresis in blood
Carbamazepine by Immunoassay in blood
Ciclosporin by Immunoassay in blood
Transferrin by Nephelometry in blood and urine
2 Macroglobulin by Nephelometry in blood and urine
ALAT by UV-Visible spectroscopy in blood
ASAT by UV-Visible spectroscopy in blood
Magnesium by UV-Visible spectroscopy in blood and urine

Considerations for determinations of sub-disciplines:

In order to determine its sub-disciplines, the laboratory should list all the measurement
techniques it uses within its scope, all the properties, which can be individual parameters or
groups of equivalent parameters, and all the products, as shown below.

Measurement techniques
Chemiluminescence
Electrochemistry
Electrophoresis
Immunoassay
Nephelometry
UV-Visible spectroscopy

Properties
Drugs (Carbamazepine, Ciclosporin)
Electrolytes (Calcium, Potassium, Magnesium)
Enzymes (ALAT, ASAT)
Hormones (FSH, LH)
Specific proteins (Cryoglobulin, Transferrin, 2Macroglobulin)
Vitamins (Folic acid)

Products
Blood
Urine

List of analyses:
From the listed measurement techniques, properties and products, the laboratory should, for
each individual parameter, link the parameter to one measurement technique, one property and
one product, as shown in the table below.

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Parameter Measurement Property Product

technique
FSH Chemiluminescence Hormones Blood
LH Chemiluminescence Hormones Blood
Folic acid Chemiliuminescence Vitamins Blood
Calcium Electrochemistry Electrolytes Blood
Calcium Electrochemistry Electrolytes Urine
Potassium Electrochemistry Electrolytes Blood
Potassium Electrochemistry Electrolytes Urine
Cryoglobulins Electrophoresis Specific Proteins Blood
Carbamazepine Immunoassay Drugs Blood
Ciclosporin Immunoassay Drugs Blood
Transferrin Nephelometry Specific Proteins Blood
Transferrin Nephelometry Specific Proteins Urine
2 Macroglobulin Nephelometry Specific Proteins Blood
2 Macroglobulin Nephelometry Specific Proteins Urine
ALAT UV-Visible spectroscopy Enzymes Blood
ASAT UV-Visible spectroscopy Enzymes Blood
Magnesium UV-Visible spectroscopy Electrolytes Blood
Magnesium UV-Visible spectroscopy Electrolytes Urine

Resulting matrix:
From the list of analyses, the laboratory can then establish a matrix, which will highlight the
sub-disciplines, as shown below. If the number of products is limited, they can be included in
the matrix. If not the evaluation of the products can be treated separately.

Property Drugs Electrolytes Enzymes Hormones Specific Vitamins

Measurement proteins
technique
Product B U B U B U B U B U B U
Chemiluminescence X X
Electrochemistry X X
Electrophosesis X
Immunoassay X
Nephelometry X X
UV-Visible X X X
Spectroscopy

Resulting sub-disciplines from this exercise:

Hormones by Chemiluminescence in blood
Vitamins by Chemiluminescence in blood
Electrolytes by Electrochemistry in blood and urine
Specific proteins by Electrophoresis in blood
Drugs by Immunoassay in blood
Specific proteins by Nephelometry in blood and urine
Electrolytes by UV-Visible spectroscopy in blood and urine
Enzymes by UV-Visible spectroscopy in blood

Note: although the different products have been combined into one sub-discipline for each
detection system in terms of being equivalent from a competency point of view, this does not
suggest that they are equivalent in terms of method and laboratory performance.

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Therefore, the laboratory would be expected to undertake such PTs specifically covering all the
products in their scope on a periodic basis. This would be expected to be clearly detailed in
their proficiency testing strategy.

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